Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)

NCT01065766 | Completed Results

• 2 other identifiers: 0431A-1822010_006
• Study Type: observational
• Target: 4,065
• Locations: 0 countries
• Sites: N/A

Brief Summary

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus; Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants With Any Adverse Experience

  An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.

  Up to 26 weeks

• Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12

  HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.

  Baseline and Week 12

• Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12

  Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.

  Baseline and Week 12

• Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12

  Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.

  Baseline and Week 12

• Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12

  Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.

  At Week 12

• Change From Baseline to Treatment in HbA1c at Week 24

  HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.

  Baseline and Week 24

• Change From Baseline to Treatment in FPG at Week 24

  Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.

  Baseline and Week 24

• Change From Baseline in 2hr-PPG at Week 24

  Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.

  Baseline and Week 24

• Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24

  Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.

  At Week 24

Study Arms (1)

All participants

Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin

Drug: Sitagliptin/metformin

Interventions

Sitagliptin/metformin DRUG

Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.

Also known as: JANUMET

All participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice

You may qualify if:

• Has type 2 diabetes mellitus
• Is treated with sitagliptin/metformin within local label for the first time

You may not qualify if:

• Has a contraindication to sitagliptin/metformin according to the local label
• Is treated with sitagliptin/metformin before contract and out of enrollment period

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Sitagliptin Phosphate; Metformin; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-888-577-8839

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: March 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 6, 2015
• Results First Posted: April 17, 2014

Record last verified: 2015-02